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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device ventilator, continuous, facility use
Regulation Description Continuous ventilator.
Product CodeCBK
Regulation Number 868.5895
Device Class 2


Premarket Reviews
ManufacturerDecision
CORVENT MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN, LLC
  SUBSTANTIALLY EQUIVALENT 1
DATEX-OHMEDA, INC.
  SUBSTANTIALLY EQUIVALENT 1
DIMAR S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
DRAEGERWERK AG & CO KGAA
  SUBSTANTIALLY EQUIVALENT 3
DRAGERWERK AG & CO KGAA
  SUBSTANTIALLY EQUIVALENT 1
FISHER & PAYKEL HEALTHCARE, LTD.
  SUBSTANTIALLY EQUIVALENT 2
FLIGHT MEDICAL INNOVATIONS , LTD.
  SUBSTANTIALLY EQUIVALENT 1
HAMILTON MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 4
HAMITON MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 1
HSINER CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ICONIC SOLUTIONS BY MURCIA, SL
  SUBSTANTIALLY EQUIVALENT 1
IMTMEDICAL AG
  SUBSTANTIALLY EQUIVALENT 1
INOVYTECH MEDICAL SOLUTIONS , LTD.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K202970  Ventway Sparrow
MAQUET CRITICA CARE AB
  SUBSTANTIALLY EQUIVALENT 1
MAQUET CRITICAL CARE AB
  SUBSTANTIALLY EQUIVALENT 2
NIHON KOHDEN ORANGEMED, INC.
  SUBSTANTIALLY EQUIVALENT 2
NIHON KOHDEN ORANGEMED, LLC
  SUBSTANTIALLY EQUIVALENT 1
OCONNELL REGULATORY CONSULTANTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORIGIN MEDICAL DEVICES
  SUBSTANTIALLY EQUIVALENT 1
RESPIRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SLEEPNET CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
TELESAIR, INC.
  SUBSTANTIALLY EQUIVALENT 1
VENTIS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
VYAIRE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZOLL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 9100 9505
2020 11096 11105
2021 13322 13333
2022 15974 15986
2023 24928 24932
2024 20336 20339
2025 14196 14199
2026 6311 6312

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 14498 14498
Output Problem 12499 12503
Circuit Failure 8625 8625
Electrical /Electronic Property Problem 6642 6642
Battery Problem 6436 6470
Failure to Recalibrate 5638 5638
Failure to Run on Battery 5235 5236
No Display/Image 4697 4697
Failure to Calibrate 4555 4821
Defective Component 3938 3938
Failure of Device to Self-Test 3785 3786
Insufficient Flow or Under Infusion 3369 3369
Failure to Power Up 3240 3243
Gas/Air Leak 2810 2811
Display or Visual Feedback Problem 2806 2806
Degraded 2780 2791
Improper Flow or Infusion 2476 2476
Failure to Charge 2346 2362
Unexpected Shutdown 2205 2206
Power Problem 1901 1944
Protective Measures Problem 1850 1889
Insufficient Information 1775 1776
Contamination 1737 1737
Infusion or Flow Problem 1664 1664
No Flow 1617 1617
Failure to Deliver 1503 1504
Gas Output Problem 1300 1301
Decrease in Pressure 1223 1225
Leak/Splash 1093 1097
Calibration Problem 1027 1027
Device Sensing Problem 1016 1016
Pressure Problem 992 992
Device Displays Incorrect Message 942 942
Therapeutic or Diagnostic Output Failure 869 871
Complete Loss of Power 764 764
Computer Software Problem 715 715
Adverse Event Without Identified Device or Use Problem 694 695
Application Program Problem 566 566
Incorrect, Inadequate or Imprecise Result or Readings 564 564
Device Alarm System 560 560
Inadequate User Interface 479 483
Communication or Transmission Problem 472 472
Use of Device Problem 454 454
Connection Problem 419 419
No Apparent Adverse Event 414 415
Increase in Pressure 381 381
Tidal Volume Fluctuations 353 353
Loose or Intermittent Connection 319 321
False Positive Result 299 299
Fracture 295 297

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 91212 91232
No Patient Involvement 8546 8547
No Consequences Or Impact To Patient 8083 8484
Insufficient Information 2149 2152
Low Oxygen Saturation 1204 1207
No Known Impact Or Consequence To Patient 1036 1038
No Information 865 865
Unspecified Respiratory Problem 570 574
Headache 375 378
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 298 298
Dizziness 269 269
Dyspnea 268 276
Death 185 188
Respiratory Failure 184 184
Asthma 178 178
Cardiac Arrest 170 170
Cancer 167 168
Respiratory Insufficiency 142 142
Unspecified Kidney or Urinary Problem 141 142
Respiratory Tract Infection 129 132
Nausea 126 126
Hypoxia 116 118
Skin Inflammation/ Irritation 107 107
Vomiting 102 102
Bradycardia 98 98
Cough 91 91
Inflammation 89 89
Ventilator Dependent 88 88
Sore Throat 77 79
Hypersensitivity/Allergic reaction 75 75
Pneumothorax 66 66
No Code Available 66 66
Respiratory Arrest 65 65
Unspecified Heart Problem 63 63
Pneumonia 58 58
Chronic Obstructive Pulmonary Disease (COPD) 55 55
Cyanosis 52 52
Hypoventilation 37 37
Unspecified Hepatic or Biliary Problem 36 36
Increased Respiratory Rate 33 33
Heart Failure/Congestive Heart Failure 32 32
Discomfort 31 31
Low Blood Pressure/ Hypotension 30 30
Apnea 30 30
Tachycardia 27 27
Loss of consciousness 27 27
Chest Pain 21 21
Respiratory Distress 20 20
Respiratory Acidosis 19 19
Pulmonary Dysfunction 18 18

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation I May-09-2025
2 Baxter Healthcare Corporation I Jan-16-2025
3 Baxter Healthcare Corporation I Oct-22-2024
4 Baxter Healthcare Corporation I Jun-26-2024
5 Baxter Healthcare Corporation I Feb-24-2023
6 Breas Medical, Inc. II Apr-15-2022
7 Covidien I Jun-09-2025
8 Covidien I Aug-02-2024
9 Covidien Llc I Dec-09-2021
10 Covidien Llc II Nov-06-2020
11 Draeger Medical, Inc. I Aug-18-2023
12 Draeger Medical, Inc. I Jul-08-2023
13 Draeger Medical, Inc. I Feb-24-2023
14 Draeger Medical, Inc. II Apr-04-2022
15 Draeger Medical, Inc. II Oct-14-2021
16 Draeger Medical, Inc. II May-28-2021
17 GE Healthcare, LLC I Jun-06-2022
18 GE Healthcare, LLC II Aug-24-2020
19 GE Healthcare, LLC II Dec-17-2019
20 Getinge Group Logistics America, LLC II Oct-09-2020
21 Getinge Usa Sales Inc II Aug-24-2022
22 Getinge Usa Sales Inc I Aug-22-2022
23 Hamilton Medical AG I Aug-19-2025
24 Hamilton Medical AG I Jun-18-2024
25 Hamilton Medical AG II Apr-25-2023
26 Hamilton Medical AG II Nov-18-2022
27 Hamilton Medical AG I Aug-19-2022
28 Hamilton Medical AG I Jul-11-2019
29 Hamilton Medical, Inc. I Sep-20-2023
30 Hamilton Medical, Inc. I Jul-21-2023
31 Hill-Rom Manufacturing, Inc. II Nov-24-2020
32 Maquet Critical Care AB I Jun-27-2025
33 Medtronic formerly Covidien I Apr-25-2022
34 NIHON KOHDEN ORANGEMED, INC II Sep-08-2021
35 Percussionaire Corporation I Jan-23-2025
36 Percussionaire Corporation I Jan-17-2024
37 Percussionaire Corporation I Jan-17-2024
38 Percussionaire Corporation II Nov-07-2023
39 Philips Respironics, Inc. I Apr-02-2026
40 Philips Respironics, Inc. I Mar-26-2026
41 Philips Respironics, Inc. I Nov-13-2024
42 Philips Respironics, Inc. I Sep-05-2024
43 Philips Respironics, Inc. I Apr-17-2024
44 Philips Respironics, Inc. II Jan-04-2024
45 Philips Respironics, Inc. II Jul-07-2023
46 Philips Respironics, Inc. I Jun-02-2023
47 Philips Respironics, Inc. I Apr-03-2023
48 Philips Respironics, Inc. I Jan-06-2023
49 Philips Respironics, Inc. I Mar-18-2022
50 Philips Respironics, Inc. I Jan-22-2022
51 Philips Respironics, Inc. II Aug-13-2021
52 Philips Respironics, Inc. I Jul-15-2021
53 Philips Respironics, Inc. I Feb-15-2020
54 ResMed Ltd. I Oct-23-2023
55 Ventec Life Systems, Inc. I Feb-26-2025
56 Ventec Life Systems, Inc. I Feb-23-2024
57 Ventec Life Systems, Inc. II Jun-21-2021
58 Vyaire Medical II Jun-15-2023
59 Vyaire Medical I Feb-16-2022
60 Vyaire Medical II Mar-04-2020
61 ZOLL Medical Corporation I Jun-20-2024
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